The following data is part of a premarket notification filed by Zoll Manufacturing Corporation with the FDA for Zoll Arrhythmia Management Sysyem.
| Device ID | K190939 |
| 510k Number | K190939 |
| Device Name: | ZOLL Arrhythmia Management Sysyem |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh, PA 15238 |
| Contact | Zachary Nelson |
| Correspondent | Michael Nilo Nilo Medical Consulting Group 5737 Kentucky Avenue #3 Pittsburgh, PA 15232 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855778005364 | K190939 | 000 |
| 00855778005357 | K190939 | 000 |
| 00855778005463 | K190939 | 000 |